Thera Plus Hydrocortisone Cream, Maximum Strength

Thera Plus Hydrocortisone Cream, Maximum Strength
SPL v2
SPL
SPL Set ID c2bc8f0c-38ea-4124-bc51-bf22e6751a92
Route
TOPICAL
Published
Effective Date 2025-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Aloe Vera Leaf Cetyl Alcohol Edetate Disodium Methylparaben Mineral Oil Petrolatum Polysorbate 20 Propylene Glycol Propylparaben Water Sorbitan Monostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-03

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses

• temporarily relieves itching associated with minor skin irritations,inflammation and rashes due to: • eczema • psoriasis • poison ivy,oak,sumac • insect bites • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • temporarily relieves external anal and genital itching • other uses of this product should be under advice and supervision of a doctor

Warnings

For external use only.

Directions

• for itching of skin irritation, inflammation, and rashes:

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

• children under 2 years of age: do not use, ask a doctor

• for external anal and genital itching

• adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly

• gently dry by patting or blotting with toilet tissue or soft cloth before applying

• apply to affected area not more than 3 to 4 times daily

• children under 12 years of age: ask a doctor

Do Not Use

• in the genital area if you have a vaginal discharge. Consult a doctor. • for the treatment of diaper rash. Consult a doctor.

Drug Facts

Questions?

1-800-639-3803Weekdays 9 AM to 4 PM EST

Other Information

• store at room temperature 68 °- 77° F (20° - 25°C).

Package Labeling:

Active Ingredients

Hydrocortisone 1%

Inactive Ingredients

aloe barbadensis leaf juice, cetyl alcohol, edetate disodium, methylparaben, mineral oil, mono-and di-glycerides, petrolatum, polyoxyl lauryl ether, polysorbate 20, propylene glycol, propylparaben, purified water, sorbitan monostearate

When Using This Product

• avoid contact with eyes.

• do not use more than directed unless told to do so by a doctor.

• do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor If

• condition worsens, symptoms persists for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

• rectal bleeding occurs 

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Structured Label Content

Uses

• temporarily relieves itching associated with minor skin irritations,inflammation and rashes due to: • eczema • psoriasis • poison ivy,oak,sumac • insect bites • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • temporarily relieves external anal and genital itching • other uses of this product should be under advice and supervision of a doctor

Purpose

Anti-itch

Warnings

For external use only.

Directions

• for itching of skin irritation, inflammation, and rashes:

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

• children under 2 years of age: do not use, ask a doctor

• for external anal and genital itching

• adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly

• gently dry by patting or blotting with toilet tissue or soft cloth before applying

• apply to affected area not more than 3 to 4 times daily

• children under 12 years of age: ask a doctor

Do Not Use (Do not use)

• in the genital area if you have a vaginal discharge. Consult a doctor. • for the treatment of diaper rash. Consult a doctor.

Drug Facts

Questions?

1-800-639-3803Weekdays 9 AM to 4 PM EST

Other Information (Other information)

• store at room temperature 68 °- 77° F (20° - 25°C).

Package Labeling:

Active Ingredients (Active ingredients)

Hydrocortisone 1%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, cetyl alcohol, edetate disodium, methylparaben, mineral oil, mono-and di-glycerides, petrolatum, polyoxyl lauryl ether, polysorbate 20, propylene glycol, propylparaben, purified water, sorbitan monostearate

When Using This Product (When using this product)

• avoid contact with eyes.

• do not use more than directed unless told to do so by a doctor.

• do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• condition worsens, symptoms persists for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

• rectal bleeding occurs 

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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